Sexual Function, Coping and Dyadic Coping in Patients With Cervical Cancer

NCT06124040UNKNOWNOBSERVATIONAL

Summary

The studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. Moreover, a baseline evaluation about sexual function and coping if often lacking. Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives: * To assess sexual function, coping, emotional distress, and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy. * To evaluate changes on the previous variables over 6 months. The results obtained will be utilized for: * planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis * develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients.

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

154

Start Date

2023-11-23

Completion Date

2024-05-31

Study Type

OBSERVATIONAL

Official Title

Sexual Function, Coping and Dyadic Coping in Cervical Cancer Patients: a Comparison Between Surgery and Radiotherapy Plus Chemotherapy

Interventions

psychological assessment evaluation

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Patients' age ≥ 18 years
* Patients undergoing non-conservative surgery or radiotherapy plus chemotherapy
* Patients able to understand and sign informed consent

Exclusion Criteria:

* Patients' age \> 65 years
* Patients with inability to express informed consent
* Patients denying informed consent
* Patients with psychopathological disturbances preexisting to the cancer diagnosis
* Patients affected by severe language deficits

Outcome Measures

Primary Outcomes

Assess sexual function in cervical cancer patients

Primary outcome is to assess sexual function of cervical cancer patients undergoing surgery vs patients undergoing radiotherapy plus chemotherapy. This dimension will be assessed by "Female Sexual Function Index" (FSFI), a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The index only measures sexual function in these domains over the previous 30 days. The FSFI can be used as a screening tool and as a potential diagnostic aid. A total cut-off score ≤ 26.55 has been proposed for the diagnosis of female sexual dysfunction, so any woman scoring below 26.55 should be considered at risk for sexual dysfunction.

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Assess individual coping strategies in cervical cancer patients

Assessment of individual coping strategies will be done in both groups by The Mini-Mental Adjustment to Cancer (Mini-MAC), a 29-item instrument that evaluates cognitive and behavioral responses to cancer. The factors of the Mini-MAC are: Fighting Spirit, Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Each item is rated on a 4-point scale that ranges from "definitely does not apply to me" to "definitely applies to me". Each statement is rated on a scale from 1 (definitely not) to 4 (definitely yes), and the available scores for each of the four coping strategies range from 7 to 28 points. The higher the score, the greater the coping/behavior style in the patient's fight against cancer.

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Secondary Outcomes

Evaluate dyadic coping in cervical cancer patients

Dyadic Adjustment Scale (DAS) will be adopted to assess the quality of romantic relationships in both patient and her partner, if any. This tool evaluates the adaptability, quality, and representation that each partner has with regard to an intimate relationship. It is a self-reporting questionnaire consisting of 32 items, divided into four subscales: dyadic satisfaction, dyadic cohesive, dyadic and affective consent. For this test there is not a real clinical cut-off, the higher the score the greater the cohesion within the couple. Minimum and maximum scores depend on the subscales: * Suscale CONSENT ON IMPORTANT ISSUES: minimum score 0, maximum 4 * Subscale SATISFACTION WITH THE STATUS OF THE RELATIONSHIP: minimum score 0, maximum 5 * Subscale DOING TOGETHER: minimum score 0, maximum 4 * Subscale SATISFACTION FOR AFFECTIVE AND SEXUAL LIFE: minimum score 0, maximum 5

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Evaluate emotional Distress in cervical cancer patients

Both groups will be administred by Distress Thermometer (DT), to evaluate emotional distress. Clinical cut-off are considered as follow: DT: \> or = 4 (scoring equal or higher than 4 means high emotional distress).

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Evaluate Anxiety and Depression in cervical cancer patients

Both groups will be administred by Hospital Anxiety and Depression Scale (HADS), to evaluate anxiety and depression. Clinical cut-off are considered as follow: HADS: 8-10 (a score lower than 8 means physiological levels of anxiety and depression; scores between 8 and 10 means the presence of anxiety and depression; scoring higher than 10 means high levels of anxiety and depression).

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Evaluate the presence of any dissociative symtoms in cervical cancer patients

The Dissociative Experience Scale (DES-II) measures a wide variety of dissociation types, including both problematic experiences and normal experiences (e.g., daydreaming). It is a screening tool for dissociative disorders, especially dissociative identity disorder and dissociative disorder not otherwise specified. It is a 28-item questionnaire answered on a percentage scale ranging from 0% to 100%. The total score can be between 0 and 100, and is obtained by dividing the global result by the number of items. Scores higher than 30 indicate high levels of dissociation and are frequently reported in psychiatric patients with dissociative symptoms, while scores higher than 40 are related to post-traumatic stress disorder. Dissociation occupies an important position in the genesis of emotional manifestations in patients affected by cancer. In cancer, dissociative or post-traumatic symptoms can be related to coping strategies of anxious preoccupation and cognitive avoidance.

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Evaluate quality of life dimensions in cervical cancer patients

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cervical Module (EORTC QLQ - CX24) is a Quality of Life questionnaire, designed to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. The QLQ-CX24 consists of 3 multi-item scales and 5 single-item scales which analyzed 3 dimensions: Symptom Experience; Body Image; Sexual/Vaginal Functioning. All subscales have a minimum score of 0 (no symptoms) and a maximum score of 4 (high presence of symptoms). In general, high scores indicate dysfunctional or pathological characteristics.

Time frame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.

Locations

Fondazione Policlinico Agostino Gemelli IRCCS, Roma, Italy

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.